MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74023253
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2011, the patient experienced instability in the knee.Upon examination, it was noticed that the bcs post of the journ art ins bcs std 5 6 rt11 had fractured.A revision surgery was performed on (b)(6) 2024 to address this adverse event.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, this case reports that 12 years following implantation a revision surgery was performed due to a fractured journey articular insert bcs std 5 6 rt11.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.A review of previous actions concluded that there is a higher than expected risk of revision surgery for the first generation of journey bcs systems.It was recommended to undertake a field safety corrective action to inform surgeons of the higher expected risk of revision, and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 RT11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18887289
• Report Number: 1020279-2024-00516
• Device Sequence Number: 3051554
• Product Code: JWH
• UDI-Device Identifier: 03596010555151
• UDI-Public: 03596010555151
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 74023253
• Device Lot Number: 09AM12922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0003-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown